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Massive new study aims to find best way to save newborns who Can't breathe

NCT ID NCT07150923

Knowledge-focused Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two training and support strategies to help hospital staff use a breathing device called a supraglottic airway (SA) during newborn resuscitation. Over 36,000 newborns and their care teams across many hospitals will take part. The goal is to see which approach leads to more frequent and earlier use of the SA when a baby needs help breathing, potentially improving outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Supraglottic airway device and implementation strategies (educational materials, local champions, training, starter packs, plus external facilitation)
What this could lead to
If successful, this could identify the most effective way to train hospital staff to use supraglottic airways, potentially improving survival and outcomes for newborns who need breathing help at birth.
What could go wrong
This is an implementation study, not a test of a new treatment. It focuses on how well hospitals adopt a device already in use, so it may not directly lead to new therapies. Results may vary across different hospitals and settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36,503 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 days and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Population 1: Hospital Staff Population 1a: Clinical providers and administrators who complete study questionnaires Clinical provider 1a inclusion criteria: * Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation * Fluent in English Administrator 1a inclusion criteria * Oversee the care of newborns on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer) * Fluent in English Clinical provider and administrator exclusion 1a criteria: No exclusion criteria Population 1b: Clinical providers who participate in qualitative interviews Clinical provider 1b inclusion criteria: * Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation * Fluent in English Clinical provider 1b exclusion criteria: No exclusion criteria Population 2: Patients who receive neonatal resuscitation at birth Inclusion Criteria: * Inborn (not transferred to the hospital after birth) * ≥34 weeks' gestation at birth, based on best obstetrical estimate * Received PPV during neonatal resuscitation (as per provider's clinical assessment) Exclusion Criteria: * Congenital diaphragmatic hernia * Airway anomalies

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Delivery room resuscitation Implementation research Infant, newborn Laryngeal mask airways Neonatal resuscitation Positive pressure ventilation Supraglottic airway

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Levine Children's Hospital

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19146, United States

  • Children's Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • ChristianaCare

    RECRUITING

    Newark, Delaware, 19718, United States

  • Cohen Children's Medical Center

    NOT_YET_RECRUITING

    Queens, New York, 11040, United States

  • Good Samaritan Hospital

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45220, United States

  • Hackensack University Medical Center

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Jacobs Medical Center at University of California San Diego Health

    NOT_YET_RECRUITING

    San Diego, California, 92037, United States

  • Lenox Hill Hospital

    NOT_YET_RECRUITING

    New York, New York, 10075, United States

  • Lucile Packard Children's Hospital

    RECRUITING

    Palo Alto, California, 94304, United States

  • MaineHealth Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • MaineHealth Mid Coast Hospital

    RECRUITING

    Brunswick, Maine, 04011, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Nationwide Children's Hospital

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • Oklahoma Children's Hospital

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Parkland Health

    RECRUITING

    Dallas, Texas, 75235, United States

  • Rady Children's NICU at Rancho Springs Medical Center

    NOT_YET_RECRUITING

    Murrieta, California, 92562, United States

  • Riley Hospital for Children

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Sharp Chula Vista Medical Center

    NOT_YET_RECRUITING

    Chula Vista, California, 91911, United States

  • Sharp Grossmont Hospital

    NOT_YET_RECRUITING

    La Mesa, California, 91942, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • South Shore University Hospital

    NOT_YET_RECRUITING

    Bay Shore, New York, 11706, United States

  • St. John's Children's Hospital

    NOT_YET_RECRUITING

    Springfield, Illinois, 62701, United States

  • Texas Children's Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of North Carolina at Chapel Hill

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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